Bagged preparation subpackaging system

Abstract

According to the bagged preparation split charging system, the split charging pipe set and the flow detection pipe set are arranged at one end of the main pipeline in parallel, the peristaltic pump is connected to the main pipeline, liquid is filled into the buffer storage bags in the flow detection pipe set at the split charging rotating speed, and according to the liquid filling weight, the liquid filling time and the liquid density of the buffer storage bags, the split charging speed is adjusted according to the split charging speed. According to the method, the average flow value of the peristaltic pump at the split charging rotating speed is calculated, and then the peristaltic pump is driven to carry out filling with the same average flow value, so that the filling time is more accurately controlled, and the flow value error caused by equal-ratio calculation of the flow at different rotating speeds through the rotating speed ratio in a traditional method is eliminated.

Description

Technical Field

[0001] The utility model relates to the technical field of biopharmaceuticals, in particular to a bagged preparation packaging system. Background Art

[0002] Preparation packaging technology is an important part of the field of biopharmaceutical technology, especially for preparation products such as cell therapy and gene therapy. However, there are still the following problems in the packaging of preparations in this field: First, since biologically active preparations cannot be sterilized during the production process, in order to avoid possible cross-contamination in various production links, pharmaceutical companies are increasingly inclined to use disposable sterile closed consumables for production and packaging. However, many of them currently rely on manually controlled packaging and exhaust, which makes the packaging and exhaust process have certain risks, and can only rely on a very high background clean environment to reduce the risk.

[0003] Second, the current production cost of cell drugs is still very high, especially for cell drugs for personalized treatment. The entire production process, including the packaging process, must minimize the waste of cell fluid. The existing technology for preparation packaging still has shortcomings in residual liquid control: the quantitative module and method used in the utility model patent with application number CN202320554893.9 are connected in series in the main pipeline. The use of a series connection will lead to an increase in residual liquid. To reduce the residual liquid, the quantitative device can only be reversed at the end of the packaging. If this action is done manually, it will become difficult for users to accept. If an automated mechanism is used to do this action, the cost will increase, and the length of the pipeline needs to be increased to have free space for the inversion action. The increase in the length of the pipeline will also increase the amount of residual liquid.

[0004] Third, the preparation packaging bags and tube sets are disposable consumables and will be discarded after packaging a batch of liquid medicine. When packaging other batches of liquid medicine, new packaging bags and tube sets must be used. The volume stability of the dosing device is an important factor in the stability of the packaging accuracy. The gross error of the dosing device processing will lead to unacceptable packaging accuracy. If strict processing accuracy standards are used to control, the cost will also be greatly increased. In real applications, relying entirely on the volume accuracy of the dosing device makes the packaging accuracy of different batches unreliable.

[0005] Therefore, it is urgent to invent a bagged preparation packaging system to effectively solve at least one of the above-mentioned technical problems. Utility Model Content

[0006] The utility model aims to provide a bagged preparation dispensing system to effectively solve at least one of the problems of aseptic packaging exhaust operation of biological preparations, cell fluid waste, and accurate measurement.

[0007] In order to achieve the above-mentioned object, the utility model provides a bagged preparation packaging system, comprising:

[0008] Mother solution bag;

[0009] A main pipeline, one end of which is connected to the mother liquid bag and the other end of which has a plurality of branch pipelines;

[0010] A flow detection tube group connected to the main pipe;

[0011] The multi-component bagging tube groups are respectively connected to different branch pipelines of the main pipeline, and the flow detection tube group is located between the multi-component bagging tube group and the mother liquid bag; each group of the sub-packaging tube groups includes a multi-component bagging pipeline and an air exhaust device; the multi-component bagging pipeline is connected in parallel to the corresponding branch pipeline and is located between the air exhaust device and the flow detection tube group;

[0012] A peristaltic pump is arranged on the main pipe and located between the mother liquid bag and the flow detection tube group;

[0013] The controller is signal-connected to the peristaltic pump, the flow detection tube set and the multi-component assembly tube set.

[0014] The flow detection tube set includes a weighing module and a cache bag, the inlet of the cache bag is connected to the main pipeline, and the weighing module is used to weigh the weight of the liquid in the cache bag.

[0015] Furthermore, the air exhaust device comprises:

[0016] A drip bucket, one end of which is connected to the liquid filling level sensor;

[0017] A terminal pinch valve, one end of which is connected to the other end of the drip bucket;

[0018] An air filter is connected to the other end of the terminal pinch valve.

[0019] Furthermore, the air filter is provided with a filter membrane, and the filtering accuracy of the filter membrane is less than or equal to 0.2 μm.

[0020] Furthermore, the air exhaust device is a gas collection bag.

[0021] Furthermore, the flow detection tube set also includes:

[0022] The flow detection bypass pinch valve is arranged on the branch pipeline of the main pipeline and is located between the main pipeline and the cache bag.

[0023] Furthermore, the packaging tube group also includes:

[0024] A subpackaging pinch tube valve, which is arranged on a branch pipeline of the main pipeline and is located between the flow detection tube group and the multi-component bagging pipeline;

[0025] A filling level sensor is arranged between the multi-component bagging pipeline and the air exhaust device.

[0026] Furthermore, the dispensing bag pipeline includes: a dispensing bag, a dispensing bag pinch valve and a dispensing bag liquid level sensor;

[0027] The sub-packaging bag is connected to a branch pipeline of the main pipeline through a sub-packaging pipeline, the sub-packaging bag liquid level sensor and the sub-packaging bag clamping valve are both arranged on the sub-packaging pipeline, and the sub-packaging bag liquid level sensor is located between the sub-packaging bag clamping valve and the sub-packaging bag.

[0028] Compared with the prior art, the beneficial effects of the utility model are mainly reflected in the following aspects:

[0029] 1. Provide a bagged preparation filling system, wherein a filling pipeline and a flow detection tube group are connected in parallel to one end of a main pipeline, rather than being connected in series in the pipeline. In the distance arrangement relative to the mother liquid bag, the position of the connection point between the flow detection tube group and the main pipeline is located before the connection point between the filling tube group and the main pipeline. The above arrangement reduces the residual cell liquid in the pipeline, thereby saving production costs.

[0030] 2. Provide a bagged preparation filling system, which uses specially designed disposable sterile closed consumables, and uses a controller to uniformly control the peristaltic pump, flow detection module and filling module, thereby realizing automatic filling and exhaust while reducing the risk of cell liquid contamination. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 It is a schematic diagram of a bagged preparation dispensing system according to a first embodiment of the utility model;

[0032] Figure 2 This is a schematic diagram of a bagged preparation packaging system according to a second embodiment of the present invention.

[0033] In the figure, 100, the dispensing tube group; 200, the flow detection tube group; 300, the dispensing bag pipeline; 1, the mother liquid bag; 2, the buffer bag; 3, the main pipeline; 4, the flow detection bypass clamp valve; 5, the weighing module; 6, the controller; 7, the peristaltic pump; 8, the dispensing bag clamp valve; 9, the dispensing bag liquid level sensor; 10, the dispensing bag; 11, the filling liquid level sensor; 12, the end clamp valve; 13, the gas collection bag; 14, the dispensing clamp valve; 15, the drip bucket; 16, the air filter. DETAILED DESCRIPTION

[0034] A bagged preparation dispensing system of the present invention will be described in more detail below in conjunction with the accompanying drawings, wherein preferred embodiments of the present invention are shown. It should be understood that those skilled in the art can modify the present invention described herein while still achieving the advantageous effects of the present invention. Therefore, the following description should be understood as being widely known to those skilled in the art, and not as a limitation to the present invention.

[0035] The present invention is described in more detail in the following paragraphs by way of example with reference to the accompanying drawings. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the accompanying drawings are in very simplified form and in non-precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.

[0036] Embodiment 1

[0037] like Figure 1 As shown, this embodiment proposes a bagged preparation filling system, including: a mother liquid bag 1; a main line 3, one end of which is connected to the mother liquid bag 1, and the other end has a plurality of branch lines; a flow detection tube group 200, connected to the main line 3; the flow detection tube group 200 includes a weighing module 5 and a cache bag 2, the cache bag 2 is connected to the main line 3, and the weighing module 5 is used to weigh the weight of the liquid in the cache bag 2; the connection method between the cache bag 2 and the weighing module 5 is that the cache bag 2 can be hung on the weighing module 5 or the cache bag 2 can be freely placed on the weighing module 5. The multi-component tube groups 100 are respectively connected to different branch pipelines of the main pipeline 3, and the flow detection tube group 200 is located between the multi-component tube groups 100 and the mother liquid bag 1; each group of the multi-component tube groups 100 includes a multi-component bagging pipeline 300 and an air exhaust device; the multi-component bagging pipeline 300 is connected in parallel to the main pipeline 3 and is located between the air exhaust device and the flow detection tube group 200; the peristaltic pump 7 is arranged on the main pipeline 3 and is located between the mother liquid bag 1 and the flow detection tube group 200; the controller 6 is signal-connected to the peristaltic pump 7, the flow detection tube group 200 and the multi-component tube group 100.

[0038] The peristaltic pump 7 is used to drive the flow direction and flow rate of the liquid and gas in the bagged preparation dispensing system of this embodiment. A section of pipeline suitable for the peristaltic pump 7 is provided on the main pipeline 3, and the material of the section of pipeline can be silica gel.

[0039] In this embodiment, the main line 3 may be composed of one or more sections of pipes and joints of different materials and specifications connected together due to the need to install the peristaltic pump 7, the clamping valve, the fusion seal, the sterile connection pipe and other functions, and may include but not limited to silicone tubes, PVC hoses, EVA hoses, TPE hoses, etc.

[0040] Preferably, the air exhaust device comprises: a drip bucket 15, one end of which is connected to the liquid filling level sensor 11; an end of a terminal clamp valve 12, one end of which is connected to the other end of the drip bucket 15; and an air filter 16, which is connected to the other end of the terminal clamp valve 12. When the liquid passes through the multi-component packaging tube set 100, the gas in the sub-packaging tube set 100 and the main pipeline 3 can be discharged to the outside of the consumables through the air filter 16.

[0041] Furthermore, the air filter 16 is provided with a filter membrane, and the filtering accuracy of the filter membrane is less than or equal to 0.2 μm.

[0042] In a specific example, the flow detection tube set 200 further includes: a flow detection bypass pinch valve 4 , which is arranged between the main line 3 and the inlet of the cache bag 2 .

[0043] The liquid in the mother liquid bag 1 is transferred to the buffer bag 2 in the flow detection tube group 200 through the main line 3 by the peristaltic pump 7 until the weighing module 5 detects the weight m1 of the liquid, stops the infusion, and records the filling time t1;

[0044] Calculate the average flow rate of the current peristaltic pump 7 according to the filling time t1, the weight m1 of the liquid, and the density ρ of the liquid;

[0045] In order to save cell liquid, after calculating the average flow value of the peristaltic pump 7 , the cell liquid in the flow detection tube set 200 is pumped back into the mother liquid bag 1 .

[0046] Furthermore, the packaging tube set 100 further includes:

[0047] The subpackaging pinch valve 14 is arranged on the branch pipeline of the main pipeline 3 and is located between the flow detection tube set 200 and the multi-component bagging pipeline 300;

[0048] The filling level sensor 11 is arranged on the branch pipeline of the main pipeline 3 and is located between the multi-component bagging pipeline 300 and the air exhaust device.

[0049] In a specific example, the dispensing bag pipeline 300 includes: a dispensing bag 10, a dispensing bag pinch valve 14 and a dispensing bag liquid level sensor 9;

[0050] The lengths of the various packaging bag pipelines 300 should be consistent.

[0051] The sub-packaging bag 10 is connected to the branch pipeline of the main pipeline 3 through the sub-packaging pipeline. The sub-packaging bag liquid level sensor 9 and the sub-packaging bag clamping valve 8 are both arranged on the sub-packaging pipeline, and the sub-packaging bag liquid level sensor 9 is located between the sub-packaging bag clamping valve 8 and the sub-packaging bag 10.

[0052] After obtaining the actual average flow value of the peristaltic pump 7, according to the volume V required by the filling bag 10 f Calculate the time t required to dispense the liquid f , for subpackaging. This subpackaging consumables has higher packaging accuracy.

[0053] It should be noted that the bagged preparation dispensing system of the present embodiment is used for filling liquid and serving as a flow path for liquid flow, so that the liquid is aseptically isolated from the external environment. Generally, after dispensing a batch of liquid, it is no longer used for other batches of liquid to avoid cross contamination. However, the flow detection bypass clamp valve 4, the dispensing clamp valve 14, the filling liquid level sensor 11, the end clamp valve 12, the dispensing bag clamp valve 8 and the dispensing bag liquid level sensor 9 do not directly contact the inner wall of the pipeline in the bagged preparation dispensing consumables, and are not connected to the pipeline in the bagged preparation dispensing consumables. The sensor used in the present embodiment is generally a non-contact sensor made of ultrasonic, photoelectric, optical fiber, capacitance and other principles. Therefore, it does not contact the fluid in the bagged preparation dispensing consumables during operation and can be used repeatedly.

[0054] Preferably, all the pinch valves in the bag dispensing pipeline 300 are normally closed, that is, the flow path can be cut off when the power is turned off, and the flow path can be connected when the power is turned on.

[0055] In summary, this embodiment provides a bagged preparation dispensing system, in which the dispensing tube group 100 and the flow detection tube group 200 are connected in parallel to one end of the main line 3, rather than in series in the main line 3. After the flow detection, the liquid in the flow detection tube can be pumped back into the mother liquid bag, and then the dispensing tube group can be directly filled, reducing the liquid remaining in the pipeline of the flow detection tube group, thereby saving production costs. The bagged preparation dispensing consumables used in the bagged preparation dispensing system are disposable sterile and sealed consumables, which can reduce the risk of liquid contamination.

[0056] Embodiment 2

[0057] like Figure 2As shown, most of the components in this embodiment are the same as those in the first embodiment, except that: in the multi-component tube assembly 200, the air exhaust device can also be set as a gas collection bag 13. Since the liquid separation is operated in a sealed environment, if there is a gas or liquid leakage in some pipes during the operation, the integrity of the entire consumables will be destroyed; by setting the gas collection bag 13, if the gas can be squeezed into the bag normally, it means that the consumables can work normally, otherwise, the consumables need to be replaced.

[0058] The remaining structures and working principles are the same as those of the first embodiment. For details, please refer to the description in the first embodiment and will not be repeated here.

[0059] Embodiment 3

[0060] In this embodiment, a method for packaging a bagged preparation is proposed, comprising the following steps:

[0061] The liquid in the mother liquid bag 1 is pumped into the buffer bag 2 in the flow detection tube group 200 through the main pipe 3 by the peristaltic pump 7, until the weighing module 5 detects that the weight of the liquid reaches the preset filling weight m1 of the buffer bag, stops the infusion, and records the filling time t1;

[0062] The average flow rate of the peristaltic pump 7 at the filling speed is calculated according to the filling time t1, the filling weight m1 of the cache bag, and the density ρ of the liquid;

[0063] According to the target packaging volume V of a single or multiple packaging bags 10 f And the average flow value, calculate the filling time t required to complete the filling f ;

[0064] Start filling. When the liquid flows through the sub-packaging bag level sensor 9, start timing until the filling time t is reached. f Stop filling.

[0065] In this embodiment, the filling process of the cache bag 2 includes: the weighing module 5 first reads the weight m of the cache bag 2. When liquid inflow is just detected, the weighing module 5 records the total weight of the cache bag 2 itself and the inflowing liquid as m0, and starts timing. After a period of time, the current total weight is m2, the timing is stopped and the filling time t1 is recorded. The calculation formula for the filling weight of the cache bag 2 is: m1=m2-m0.

[0066] Specifically, after the average flow value of the peristaltic pump 7 at the filling speed is calculated, the liquid in the flow detection tube set 200 is pumped back to the mother liquid bag through the peristaltic pump 7.

[0067] Next, the filling time t is obtained. fThe calculation formula is: f =V f ×ρ / (m1×t1), where V f is the target filling volume of the filling bag 10, m1 is the filling weight of the cache bag, ρ is the density of the liquid, and t1 is the filling time of the cache bag.

[0068] Specifically, before starting filling, the main line 3 is vented, and the process of the venting operation includes: pumping the liquid in the mother liquid bag 1 to the branch pipeline of the main line 3 through the peristaltic pump 7 until the liquid reaches the filling level sensor 11, and discharging the air in the main line 3 through the air exhaust device.

[0069] Furthermore, after the main pipe 3 is exhausted, the terminal clamping valve 20 is closed, the clamping valve 17 of the sub-packaging bag is opened, and filling is started.

[0070] Furthermore, after the filling is completed, in order to reduce the waste of liquid, the sub-filling bag clamp valve 17 is closed, and the liquid in the main line 3 is pumped back into the mother liquid bag 1 through the peristaltic pump 6 .

[0071] Specifically, after the liquid in the main line 3 is pumped back to the mother liquid bag 1, the sub-packaging bag clamp valve 22 is opened, and the liquid in the sub-packaging bag 1 is pumped back by the peristaltic pump 6 until the liquid is delivered to the sub-packaging bag liquid level sensor 23, and the pumping is stopped. The purpose of this step is to exhaust the sub-packaging bag 24.

[0072] It should be noted that, based on the needs of the actual scenario, the packaging volume V of each packaging bag 24 in the same group packaging pipeline 300 is f The same group of packaging tubes 100 may have different packaging volumes V. f The packing bag 24 is prepared and the above steps are repeated to achieve packing.

[0073] If there are multiple groups of packaging tube groups 100 that need to be packaged, switch to the next group and repeat the above steps until all the packaging bags 24 are filled.

[0074] In summary, this embodiment provides a method for packaging a bagged preparation, by reading the liquid filling weight m1 of the buffer bag and the density ρ of the liquid, and then using different target packaging volumes V f Use the peristaltic pump to transport the cell liquid at the corresponding speed, record the filling time t1, and finally get the actual time formula for completing the packaging: t f =V f×ρ / (m1×t1) is used to eliminate the flow rate error caused by the traditional method of using the speed ratio to proportionally estimate the flow rate at different speeds.

[0075] In addition, the method performs multiple exhaust treatments on the cell liquid in each step in the disposable sterile sealed consumables, which can further improve the accuracy of packaging.

[0076] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A bagged preparation packaging system, characterized in that: include: Mother solution bag; A main pipeline, one end of which is connected to the mother liquid bag and the other end of which has a plurality of branch pipelines; A flow detection tube group connected to the main pipe; The multi-component bagging tube groups are respectively connected to different branch pipelines of the main pipeline, and the flow detection tube group is located between the multi-component bagging tube group and the mother liquid bag; each group of the sub-packaging tube groups includes a multi-component bagging pipeline and an air exhaust device; the multi-component bagging pipeline is connected in parallel to the corresponding branch pipeline and is located between the air exhaust device and the flow detection tube group; A peristaltic pump is arranged on the main pipe and located between the mother liquid bag and the flow detection tube group; A controller, signal-connected to the peristaltic pump, the flow detection tube set, and the multi-component assembly tube set; The flow detection tube set includes a weighing module and a cache bag, the inlet of the cache bag is connected to the main pipeline, and the weighing module is used to weigh the weight of the liquid in the cache bag.

2. The bagged preparation dispensing system according to claim 1, characterized in that: The air discharge device comprises: A drip bucket, one end of which is connected to a filling liquid level sensor; A terminal pinch valve, one end of which is connected to the other end of the drip bucket; An air filter is connected to the other end of the terminal pinch valve.

3. The bagged preparation dispensing system according to claim 2, characterized in that: The air filter is provided with a filter membrane, and the filtering accuracy of the filter membrane is less than or equal to 0.2 μm.

4. The bagged preparation dispensing system according to claim 1, characterized in that: The air exhaust device is a gas collection bag.

5. The bagged preparation dispensing system according to claim 1, characterized in that: The flow detection tube set also includes: A flow detection bypass pinch valve is arranged between the main line and the inlet of the cache bag.

6. The bagged preparation dispensing system according to claim 1, characterized in that: The packaging tube group also includes: A subpackaging pinch tube valve is arranged on a branch pipeline of the main pipeline and is located between the flow detection tube set and the multi-component bagging pipeline; The filling liquid level sensor is arranged on the branch pipeline of the main pipeline and is located between the multi-component bagging pipeline and the air exhaust device.

7. The bagged preparation dispensing system according to claim 1, characterized in that: The dispensing bag pipeline comprises: a dispensing bag, a dispensing bag pinch valve and a dispensing bag liquid level sensor; The sub-packaging bag is connected to a branch pipeline of the main pipeline through a sub-packaging pipeline, the sub-packaging bag liquid level sensor and the sub-packaging bag clamping valve are both arranged on the sub-packaging pipeline, and the sub-packaging bag liquid level sensor is located between the sub-packaging bag clamping valve and the sub-packaging bag.

Images